Islet Autotransplantation in Patients at Very High-risk Pancreatic Anastomosis (PAN-IT)

San Donato Group (GSD)

Status and phase: Completed; Phase 2

Conditions: Postpancreatectomy Hyperglycemia

Treatments: Procedure: Total pancreatectomy with islet autotransplantation; Procedure: Pancreaticoduodenectomy with pancreatic anastomosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01346098

PAN-IT

Details and patient eligibility

About

The goal of the proposal is to demonstrate that, in patients with disease of the pancreatic head with very high-risk of complications of pancreatojejunal reconstruction (soft pancreas and pancreatic duct diameter <3 mm), total pancreatectomy with islet autotransplantation (IAT) is associated with a lower morbidity (in terms of surgical or medical complications) and mortality compared with pancreaticoduodenectomy and pancreatojejunal anastomosis.

Full description

Complications of the pancreatic anastomosis still represents a significant risk for death after the resection of the pancreatic head. In an effort to decrease morbidity and mortality, the referral of patients who need a pancreaticoduodenectomy to institutions (and surgeons) performing a high volume of this surgical procedure has been championed. Nonetheless, the role of prophylactic medications and the best surgical technique(s) for the removal of the pancreatic head are still debated. However, very few prospective randomized clinical trials have been conducted to compare different surgical techniques.

Our study will address for the first time the role for preemptive total pancreatectomy and IAT in selected patients undergoing pancreaticoduodenectomy that are considered high risk for pancreaticojejunostomy disruption (eg, small pancreatic duct, soft pancreas). The information expected is the identification of total pancreatectomy and the IAT as the standard treatment in a subgroup of patient with pathologies of the pancreatic head at high risk for leakage of pancreatic anastomosis. Ultimately this project will lead to reserve more innovative cell therapy for patients with the highest risk of anastomosis failure reducing pancreatojejunal reconstruction related morbidity and mortality

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients >18 years of age
• Ability to provide written informed consent
• Mentally stable and able to comply with the procedures of the study protocol
• Fasting glycaemia <126 mg/dl without glucose-lowering medications.

Exclusion criteria

• Any medical condition that, in the opinion of the investigator, will interfere with the safe completion of the trial
• Diagnosis of intraductal papillary mucinous cancer, unless the absence of multifocal lesion is demonstrated by endoscopic US
• Presence of multifocal or residual disease at the pancreatic margin.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

GROUP B

Experimental group

Description:

At the time of surgery the surgeon will directly assess pancreatic consistency and the pancreatic duct size. In the presence of a soft pancreas and a small duct (diameter \<3 mm), the patient will be randomly assigned to receive either a pancreaticoduodenectomy with pancreatic anastomosis (group A) or a total pancreatectomy with IAT (group B).

Treatment:

Procedure: Total pancreatectomy with islet autotransplantation

GROUP A

Active Comparator group

Treatment:

Procedure: Pancreaticoduodenectomy with pancreatic anastomosis